Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT01371630
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
  • B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative
  • Burkitt-Like Lymphoma With 11q Aberration
  • High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements
  • High Grade B-Cell Lymphoma, Not Otherwise Specified
  • Recurrent B Acute Lymphoblastic Leukemia
  • Recurrent Burkitt Lymphoma
  • Refractory B Acute Lymphoblastic Leukemia
  • Refractory Burkitt Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Blinatumomab — BIOLOGICAL
    Given CIVI
  • Cyclophosphamide — DRUG
    Given IV
  • Cytarabine — DRUG
    Given IT and IV
  • Dexamethasone — DRUG
    Given IV or PO
  • Inotuzumab Ozogamicin — BIOLOGICAL
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Mercaptopurine — DRUG
    Given PO
  • Methotrexate — DRUG
    Given IT, IV, and PO
  • Prednisone — DRUG
    Given PO
  • Rituximab — BIOLOGICAL
    Given IV
  • Vincristine — DRUG
    Given IV

Study Details

This phase I/II trial studies the side effects and best dose of inotuzumab ozogamicin and to see how well it works when given together with combination chemotherapy in treating patients with acute lymphoblastic leukemia. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called N-acetyl-gamma-calicheamicin dimethyl hydrazide (CalichDMH). Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers CalichDMH to kill them. Immunotherapy with monoclonal antibodies, such as blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin together with combination chemotherapy may be a better treatment for acute lymphoblastic leukemia.

Key Dates

Start date
Aug 26, 2011
Status verified
Dec 2025
Primary completion
Dec 25, 2027
Completion
Dec 25, 2027

Study Design

Enrollment
276 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (inotuzumab ozogamicin, combination chemotherapy)
    See Detailed Description Arm I
  • Experimental: Arm II (inotuzumab ozogamicin, combination chemotherapy)
    See Detailed Description Arm II
  • Experimental: Arm III (inotuzumab ozogamicin, combination chemotherapy)
    See Detailed Description Arm III

Primary Outcome Measure

Maximum tolerated dose of inotuzumab ozogamicin based on incidence of dose limiting toxicities (Phase I) [ Time Frame: 28 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Elias Jabbour
[email protected]
713-792-7026
Elias Jabbour (PRINCIPAL_INVESTIGATOR)

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By research site
M D Anderson Cancer Center· Houston, TX

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